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Melcare Biomedical Pty Ltd was cited for selling two unapproved OTC eye care products—Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops—in violation of sections 505(a) and 301(d) of the FD&C Act. The products were classified as drugs based on labeling claims indicating use for temporary relief of irritation due to dryness and other therapeutic purposes, yet they had not received FDA approval as new drugs. Additionally, the products were found to be misbranded under section 502(ee) of the FD&C Act, with violations identified across the company's website, product labeling, and linked YouTube content where the products were offered for purchase in the United States.